There is a national epidemic of cognitive impairment in the world. In the United States alone, millions of individuals suffer from the most common form of cognitive impairment, Alzheimer's disease. Millions more suffer from some type of dementia, such as Parkinson's disease dementia, Lewy body dementia, fronto-temporal dementia, vascular and stroke dementia, and traumatic brain injury dementia. The number of individuals affected by dementia in the United States alone is expected to swell to 15 million people by 2025, which if true, will have a devastating economic impact of billions of dollars yearly in direct and indirect costs to society. Thus, there is a tremendous need for clinical care and research on cognitive and memory disorders. At any given time, approximately one quarter of all hospital patients aged 65 and older are dealing with Alzheimer's disease or other dementias. These patients typically have more complications than those without a memory disorder, require additional resources, and are more likely to be readmitted to a healthcare facility later.
Recent biomarker studies (neuroimaging with amyloid PET scans or cerebrospinal fluid) indicate that the biological process for Alzheimer's disease starts early in an asymptomatic manner, perhaps even twenty years before symptoms begin. This knowledge has led to a revision in the diagnosis and staging of Alzheimer's disease with the hope that early detection will lead to early treatment and offer a better prognosis. Alzheimer's disease is now divided into an 1) asymptomatic preclinical phase, 2) a symptomatic pre-dementia phase referred to as mild cognitive impairment (MCI), and 3) a dementia phase. The pre-dementia phase is also divided into 3 stages: the first characterized by asymptomatic amyloidosis, the second shows evidence of synaptic dysfunction, and the third has subtle cognitive changes not evident in day-to-day behavior. The Centers for Medicare & Medicaid Services (CMS) has now mandated cognitive screening annual physical examinations to begin detecting the various stages. Moreover, identifying individuals with cognitive impairment without dementia, also known as mild cognitive impairment (MCI), is useful in treating patients at an earlier stage. A significant percentage of the elderly population (65+) are at risk for MCI, and this risk increases as patients age.
Cognitive impairments are not limited to solely the elderly. Concussions and other types of head trauma occur in many areas of life, e.g., accidents, etc. Research is continuing to evolve and reveal how repetitive head trauma can greatly increase a person's chance for acquiring later memory disorders. Even mild repetitive head trauma, such as blows to the head that do not leave a person woozy or seeing stars is showing to be the cause of later memory problems in life. The first step in treating cognitive impairments caused by head trauma is to first diagnose their occurrence.
Traditional cognitive evaluations have not progressed into the digital age. Diagnostic testing is typically conducted on paper with a clinician observing or manually grading the results. For example, a patient may be instructed to trace a line through a maze on a piece of paper while a clinician times the exercise and evaluates how close inside the maze lines the patient draws. Or a clinician may time how fast a patient touches a sequence of colored dots on a piece of paper. Manually administering and scoring tests introduces a level of human error to the testing process.
Modern computer tablets, smart phones, and other computing devices have evolved rapidly over the years, boasting incredibly fast processors, speedy Web connections, ample computer memory, and very precise touch screens. This combination of computing power has led to a proliferation in software applications being designed as all sorts of unique and specialized tools. There have been myriad cognitive enhancement products that address the wellness market. But there is no mobile medical device approved by the Food and Drug Administration (FDA) developed specifically as a medical device for the clinical assessment of MCI, traumatic brain injuries, Alzheimer's disease, and other dementias.